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Completed

NCT Number: NCT01972659

Effects of Magnesium Sulphate on Sugammadex Reversal of Rocuronium Induced Blockade in Gynaecology Patients

Background: The aim of this prospective study was to evaluate the effect of magnesium on the reversal of rocuronium-induced neuromuscular block by sugammadex.

Methods: Eighty patients, aged 18 to 60 years, American Society of Anesthesiologists I-II, undergoing elective gynecological surgery were enrolled. Anaesthesia was induced with propofol and fentanyl and was maintained with 60% nitrous oxide and Oxygen in sevoflurane. The magnesium group received 50 milligram/kilogram (mg/kg) Magnesium intravenous (iv) as a bolus and 15 mg/kg/hour by continuous infusion until the completion of surgery. The placebo group received the equivalent volume of isotonic saline. For intubation, 0.6 mg/kg rocuronium was administered and 0.1 mg/kg was added when Train of four (TOF) counts reached 1 or more during the procedure. At the end of the surgery at a TOF count of 1, 4 mg/kg sugammadex iv was administered. Patients were observed until a TOF ratio of 0.9 was achieved. Patient-controlled analgesia with intravenous morphine was used postoperatively.

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Key information

Conditions

Pre-eclampsia Aggravated

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Kocaeli University Hospital

Kocaeli, 41380, Turkey (Türkiye)

About this study

Inclusion criteria

  • American Society of Anesthesiologists physical status I or II
  • 18-60 years of age
  • undergoing elective gynecological surgery
  • requiring endotracheal intubation

Exclusion criteria

  • Patients who had body mass index > 35
  • gastroesophageal reflux
  • a history of allergy
  • used medication known to interact with the drugs being used in this trial
  • who experienced expected or unexpected difficulty during intubation or ventilation
  • had neuromuscular disease
  • hepatic or renal insufficiency
  • pregnant
  • were American Society of Anesthesiologists III or IV
  • had a family history of malignant hyperthermia
  • detection if low or high control plasma magnesium levels

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • female patients
  • American Society of Anesthesiologists (ASA) physical status I or II
  • 18-60 years of age who were undergoing elective gynecological surgery
  • requiring endotracheal intubation were enrolled in this prospective study.

Exclusion criteria

  • Patients who had body mass index > 35
  • gastroesophageal reflux
  • a history of allergy
  • used medication known to interact with the drugs being used in this trial
  • who experienced expected or unexpected difficulty during intubation or ventilation
  • had neuromuscular disease
  • hepatic or renal insufficiency
  • were pregnant
  • had a family history of malignant hyperthermia
  • detection if low or high control plasma magnesium levels

Treatment and study plan

Placebo

Drug

Active comparator 50 mg/kg iv bolus plus 15 mg/kg continuous infusion

Other names: %0.9 NaCl, isotonic saline

Magnesium sulphate

Drug

Experimental :

50 mg/kg bolus plus 15 mg/kg continuous infusion

Other names: magnesium

Sugammadex

Drug

4 mg/kg iv bolus at the end of the surgery

Other names: bridion

Primary outcomes

  1. TOF 0.9 Achieving Time

    Time frame: end of the surgery

Secondary outcomes

  1. Rocuronium Onset Time

    Time frame: during the surgery

  2. Rocuronium Supplementation

    Time frame: during surgery

  3. Postoperative Morphine Consumption

    Time frame: after 12 hour surgery

Sponsors and collaborators

Lead sponsor

Kocaeli University

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Oct 30, 2013
Registry last updated
Feb 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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